OBJECTIVE To clarify the roles and functions of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs， and to provide theoretical and practical support for their transformation from traditional drug managers to multi-dimensional roles in clinical research. METHODS Combined with relevant regulations such as the Good Clinical Practice （GCP） （2020 Edition）， and based on the clinical practice experience of the Phase Ⅰ Clinical Ward in our hospital， this study systematically sorted out full-time pharmacists’ roles and functions in early-phase clinical trials of antineoplastic drugs， and explored the core challenges and optimization pathways for role transformation and capacity-building of domestic full-time clinical trial pharmacists. RESULTS & CONCLUSIONS Full-time pharmacists assumed multiple roles in early-phase clinical trials of antineoplastic drugs， including providing pharmaceutical support for protocol design， implementing whole-process standardized management of clinical trial drugs， ensuring medication safety for clinical trial subjects/participants， conducting quality control throughout the clinical trial process， and serving as a bridge for interdisciplinary collaboration and communication. Currently， there are challenges in this field in China， such as unclear roles， an imperfect capacity building system， and insufficient regulatory support. This paper proposes that by establishing a standardized role framework， clarifying the core responsibilities and authorities of full-time pharmacists， and leveraging cutting-edge technologies to provide comprehensive support for their roles， so as to fully harness their pharmaceutical expertise and contribute to the standardization and efficiency of the antineoplastic new drug development process.

OBJECTIVE: To explore the effectiveness of additional anti-rotation steel plate assisted intramedullary nail technology in treatment of aseptic femoral non-union patients. METHODS: A retrospective analysis was conducted on 21 patients with aseptic femoral non-union who admitted between September 2020 and October 2024 and treated with additional anti-rotation steel plate assisted intramedullary nail technology. There were 17 males and 4 females, aged 25-67 years (mean, 44 years). There were 19 cases of femoral anterograde intramedullary nail fixation, 1 case of femoral retrograde intramedullary nail fixation, and 1 case of steel plate fixation with fatigue fracture. There were 9 cases of hypertrophic non-union and 12 cases of atrophic non-union. All patients had varying degrees of fracture end atrophy/sclerosis. Among them, 20 patients who were fixed with intramedullary nails underwent removal of soft tissue and hardened bone at the fracture end, and cortical treatment resulted in the appearance of "chili sign" at the fracture end. Iliac bone grafting and anti-rotation steel plate fixation were performed. One patient with steel plate fixation was removed the steel palte and fixed with a retrograde intramedullary nail, while the hardened bone at the fracture end was removed, iliac bone grafting and anti-rotation steel plate fixation were performed. Postoperative follow-up observation included the incision healing, maximum knee flexion range of motion, bone healing, length of lower limbs, and subjective satisfaction. The lower extremity functional scale (LEFS) score was used to evaluate the lower limb function. RESULTS: All incisions healed by first intention. All patients were followed up 7-26 months (mean, 15.5 months). At last follow-up, the femoral fracture healed with the obvious callus formation at the fracture end; the maximum knee flexion range of motion was 95°-127° (mean, 112.67°). The LEFS score increased from 29.9±6.7 before operation to 75.9±3.0 at last follow-up, and the difference was significant (t=-29.622, P<0.001). Except for 1 patient who underwent intramedullary nail dynamic treatment before operation and had a lower limb shortening of about 0.9 cm, the other patients had bilateral lower limbs of equal length. All patients had no postoperative infections, mal-union of fractures, deep vein thrombosis, joint stiffness, or other complications. CONCLUSION The use of additional anti-rotation steel plate assisted intramedullary nail technology in the treatment of aseptic femoral non-union not only overcomes the drawbacks of insufficient stability at the fracture end of intramedullary nails, but also overcomes the shortcomings of biased fixation with steel plates. It has the advantages of minimal trauma, effective maintenance of fracture stability, and ideal postoperative functional recovery, making it an effective treatment for aseptic femoral non-union.
Humans ; Male ; Fracture Fixation, Intramedullary/instrumentation* ; Female ; Bone Plates ; Middle Aged ; Adult ; Femoral Fractures/surgery* ; Retrospective Studies ; Bone Nails ; Aged ; Fractures, Ununited/surgery* ; Treatment Outcome ; Bone Transplantation/methods* ; Steel ; Fracture Healing

Objective： The aim of this study is to explore the predictive value of biparametric magnetic resonance imaging(bpMRI)for pelvic lymph node metastasis in prostate cancer patients with PSA≤20 μg/L and establish a nomogram. Methods： The imaging data and clinical data of 363 patients undergoing radical prostatectomy and pelvic lymph node dissection in the First Affiliated Hospital of Nanjing Medical University from July 2018 to December 2023 were retrospectively analyzed. Univariate analysis and multivariate logistic regression were used to screen independent risk factors for pelvic lymph node metastasis in prostate cancer, and a nomogram of the clinical prediction model was established. Calibration curves were drawn to evaluate the accuracy of the model. Results： Multivariate logistic regression analysis showed extrocapusular extension (OR=8.08,95%CI=2.62－24.97, P<0.01), enlargement of pelvic lymph nodes (OR=4.45,95%CI=1.16－17.11,P=0.030), and biopsy ISUP grade(OR=1.97,95%CI=1.12－3.46, P=0.018)were independent risk factors for pelvic lymph node metastasis. The C-index of the prediction model was 0.834, which indicated that the model had a good prediction ability. The actual value of the model calibration curve and the prediction probability of the model fitted well, indicating that the model had a good accuracy. Further analysis of DCA curve showed that the model had good clinical application value when the risk threshold ranged from 0.05 to 0.70.Conclusion： For prostate cancer patients with PSA≤20 μg/L, bpMRI has a good predictive value for the pelvic lymph node metastasis of prostate cancer with extrocapusular extension, enlargement of pelvic lymph nodes and ISUP grade≥4.
Humans ; Male ; Prostatic Neoplasms/diagnostic imaging* ; Lymphatic Metastasis ; Retrospective Studies ; Nomograms ; Prostate-Specific Antigen/blood* ; Lymph Nodes/pathology* ; Pelvis ; Predictive Value of Tests ; Prostatectomy ; Lymph Node Excision ; Risk Factors ; Magnetic Resonance Imaging ; Logistic Models ; Middle Aged ; Aged

Colorectal tumorigenesis generally progresses from adenoma to adenocarcinoma, accompanied by dynamic changes in the tumor microenvironment (TME). A randomized controlled trial has confirmed the efficacy and safety of Shen-Bai-Jie-Du decoction (SBJDD) in preventing colorectal tumorigenesis. However, the mechanism remains unclear. In this study, we employed single-cell RNA sequencing (scRNA-seq) to investigate the dynamic evolution of the TME and validated cell infiltration with multiplex immunohistochemistry and flow cytometry. Bulk RNA sequencing was utilized to assess the underlying mechanisms. Our results constructed the mutually verifiable single-cell transcriptomic atlases in Apc ^Min/+ mice and clinical patients. There was a marked accumulation of CCL22⁺ dendritic cells (DCs) and an enhanced immunosuppressive action, which SBJDD and berberine reversed. Combined treatment with cholesterol and lipopolysaccharide induced characteristic gene expression of CCL22⁺ DCs, which may represent "exhausted DCs". Intraperitoneal injection of these DCs after SBJDD treatment eliminated its therapeutic effects. TMEM131 derived CCL22⁺ DCs generation by TNF signaling pathway and may be a potential target of berberine in retarding colorectal tumorigenesis. These findings emphasize the role of exhausted DCs and the regulatory mechanisms of SBJDD and berberine in colorectal cancer (CRC), suggesting that the multi-component properties of SBJDD may help restore TME homeostasis and offer novel cancer therapy.

Objective To observe the ultrasonic manifestations of abdominal pregnancy.Methods Ultrasonic and clinical data of 18 pregnant woman with abdominal pregnancy diagnosed by operation and pathology were retrospectively analyzed.Results Among 15 cases in first trimester,no preoperative ultrasonic diagnosis of abdominal pregnancy was obtained.Ultrasound showed no gestational sac in uterine cavity but mass in pelvic cavity,which located in the adnexal region in 8 cases,in the front and the post of uterus each in 2 cases,while in the adnexal region and the front of uterus in 1 case,in the post of the cervix in 1 case,and closed to uterine wall in 1 case,without obvious tubal echo around mass in all 15 cases.There were 2 cases of abdominal pregnancy in the second trimester,which were first diagnosed with ultrasound at 13+6 weeks and 21 weeks,with gestational sac located on the left side of uterus and behind the uterus,respectively.One case of abdominal pregnancy in the third trimester was first diagnosed with ultrasound at 35 4 weeks,with gestational sac located on the right side of uterus.Ultrasonic manifestations of the above three cases all showed gestational sac located outside the uterus without myometrium wrapping around the gestational sac nor placenta implanted in uterus,while echoes of fluid accumulation were detected around fetus.The ultrasonic diagnosis rate of abdominal pregnancy was 16.67％(3/18).Conclusion In the first trimester,if the ectopic pregnancy mass was large or the gestational sac located adjacent to the cervix,anterior or posterior to uterus and on the uterine wall,also no fallopian tube-like echo around the mass,the possibility of abdominal pregnancy should be considered.Ultrasonic manifestations of abdominal pregnancy in the second and third trimester present as gestational sac outside uterine cavity without wrapping uterine muscle layer around,no placenta implantation in uterine cavity,as well as echoes of fluid accumulation around fetus.Transabdominal combined with transvaginal ultrasound could improve diagnostic rate of abdominal pregnancy.

Objective To observe the effects of Ditan Yizhi Decoction on Wnt/β-catenin signaling pathway and mitochondrial autophagy in vascular dementia(VD)rats.Methods Totally 70 male SD rats were randomly selected as the sham-operation group,with only the common carotid artery isolated and not ligated,and the rest of the rats were used to prepare a rat model of VD by the modified bilateral common carotid artery permanent ligature method.The successfully modeled rats were randomly divided into model group,donepezil group,agonist group and Ditan Yizhi Decoction low-,medium-and high-dosage groups and were given corresponding interventions for 4 weeks.Morris water maze experiment was used to assess the learning and memory ability of rats,HE staining and Nissl staining were used to observe the morphology of hippocampal tissue,transmission electron microscopy was used to observe the ultrastructure of hippocampal neuron,Western blot was used to detect the expressions of PINK1,Parkin,p62,Beclin-1,LC3BⅡ/Ⅰ,β-catenin,GSK-3β,p-GSK-3β protein.Results Compared with the sham-operation group,rats in the model group had a prolonged escape latency(P<0.01),a reduced number of crossing platforms(P<0.01);neuronal gaps in the CA1 area of the hippocampus were enlarged,with irregular cell morphology and blurred borders,neuronal solidification,Nissl bodies dissolution and fragmentation,reduced quantity,mitochondrial cristae disorder,and disruption of the structure of the bilayer membrane,with a greater number of autophagosomes in the surroundings;the expressions of PINK1,Parkin,Beclin-1,LC3BⅡ/I,β-catenin,p-GSK-3β/GSK-3β protein were significantly increased(P<0.01),and p62 protein expression was significantly decreased(P<0.01).Compared with the model group,the escape latency of rats in donepezil group,agonist group and Ditan Yizhi Decoction low-,medium-and high-dosage groups were significantly shortened(P<0.01),and the number of crossing platforms significantly increased(P<0.05,P<0.01);the number of neurons in the hippocampal CA1 region increased,with normal morphology and orderly arrangement,Nissl bodies were abundant,and transmission electron microscopy showed that mitochondrial morphology recovered,rupture decreased,and autophagosomes around mitochondria decreased,the protein expressions of PINK1,Parkin,Beclin-1,LC3BⅡ/Ⅰ,β-catenin and p-GSK-3β/GSK-3β in hippocampal tissue were significantly decreased(P<0.01),the protein expression of p62 significantly increased(P<0.05,P<0.01).Conclusion Ditan Yizhi Decoction can improve learning memory ability and neuronal morphology in VD rats,and its mechanism may be related to the activation of Wnt/β-catenin signaling pathway to inhibit mitophagy.

Objective To investigate the drivers,stakeholders,core tasks,and differentiated development models of digital transformation in Chinese hospitals,develop a hospital digital transformation model,and propose advancement pathways.Methods Leveraging ROCCIPI theory,socio-technical systems theory,and social network theory,a multiple case study approach was employed to analyze four representative Chinese hospitals,examining the driving factors,social network relationship,and core tasks of digital transformation.Results Hospital digital transformation is a complex process driven by regulations,opportunities,and capabilities,requiring efficient collaboration among stakeholders focused on patient services,clinical operations,hospital management,and security.It identified three development models-ecology-oriented,regional integration,and grassroots enhancement—based on the distinct characteristics of the hospitals.A theoretical model for digital transformation in four Chinese hospitals was developed,along with proposed pathways and strategies.Conclusion It presents a digital transformation model and advancement pathways for hospitals through multiple case analyses,addressing the limited perspectives of existing research and providing a reference for practice.

Objective To observe the effects of Ditan Yizhi Decoction on mitochondrial dynamics-mediated glucose metabolism in vascular dementia(VaD)rats based on the ROS/Drp1 axis;To explore its mechanism in treating VaD.Methods Ten male SD rats were randomly selected from 70 as the sham-operation group,and VaD models were prepared using the modified bilateral common carotid artery permanent ligation method for the remaining rats.The successfully modeled rats were randomly divided into model group,positive drug group(donepezil hydrochloride),inhibitor group(Mdivi-1)and Ditan Yizhi Decoction low-,medium-and high-dosage groups(12.86,25.725,51.45 g/kg),and intervened with corresponding method for 4 consecutive weeks.Morris water maze experiment was used to assess the learning memory ability of rats,HE and Nissl staining were used to observe the morphology of hippocampal tissue,transmission electron microscopy was used to observe the mitochondrial ultrastructure of hippocampal neurons,DHE fluorescent probe was used to detect the content of ROS in hippocampal neurons,Western blot was used to detect the expressions of Drp1,p-Drp1,Mfn2,Opa1,HK1,PKM2,GLUT1 and LDHA,the contents of serum IL-1β,IL-6 and TNF-α were detected by ELISA.Results Compared with the sham-operation group,rats in the model group had a prolonged escape latency(P<0.01)and a reduced number of crossing platforms(P<0.01);neuronal gaps in the CA1 region of the hippocampus were enlarged,with irregular cell morphology and blurred borders,neuronal consolidation,lysis and fragmentation of Nissl bodies and reduced number of Nissl bodies,swelling and deformation of mitochondria,disorganization of the cristae,and disruption of the bilayer membrane structure;the content of ROS in CA1 region of the hippocampus was elevated,the protein expressions of Mfn2 and Opa1 significantly decreased(P<0.01),the expressions of p-Drp1,HK1,PKM2,GLUT1,LDHA proteins significantly increased(P<0.01),and serum contents of IL-1β,IL-6 and TNF-α significantly increased(P<0.01).Compared with the model group,the escape latency was significantly shortened in Ditan Yizhi Decoction groups,positive drug group and inhibitor group(P<0.01),and the number of crossing platforms increased(P<0.05,P<0.01);the number of neurons in the hippocampal CA1 region increased,with normal morphology,orderly arrangement,abundant Nissl bodies,recovered mitochondrial morphology,and decreased rupture;the ROS content in hippocampal CA1 region decreased(P<0.01),while the expressions of Mfn2 and Opa1 proteins increased(P<0.01),the expressions of p-Drp1,HK1,PKM2,GLUT1 and LDHA proteins decreased(P<0.01),and the serum contents of IL-1β,IL-6 and TNF-α decreased(P<0.05).Conclusion Ditan Yizhi Decoction can improve cognitive impairment and neuronal morphology in VaD rats,and the mechanism maybe related to regulation of mitochondrial dynamics through the ROS/Drp1 axis,attenuating glycometabolic disorders,and reducing inflammatory response.

OBJECTIVE: To investigate the effect of manual acupuncture manipulations (MAMs) on subcutaneous muscle tissue, by developing quantitative models of "lifting and thrusting" and "twisting and rotating", based on machine learning techniques. METHODS: A depth camera was used to capture the acupuncture operator's hand movements during "lifting and thrusting" and "twisting and rotating" of needle. Simultaneously, the ultrasound imaging was employed to record the muscle tissue responses of the participants. Amplitude and angular features were extracted from the movement data of operators, and muscle fascicle slope features were derived from the data of ultrasound images. The dynamic time warping barycenter averaging algorithm was adopted to align the dual-source data. Various machine learning techniques were applied to build quantitative models, and the performance of each model was compared. The most optimal model was further analyzed for its interpretability. RESULTS: Among the quantitative models built for the two types of MAMs, the random forest model demonstrated the best performance. For the quantitative model of the "lifting and thrusting" technique, the coefficient of determination (R²) was 0.825. For the "twisting and rotating" technique, R² reached 0.872. CONCLUSION Machine learning can be used to effectively develop the models and quantify the effects of MAMs on subcutaneous muscle tissue. It provides a new perspective to understand the mechanism of acupuncture therapy and lays a foundation for optimizing acupuncture technology and designing personalized treatment regimen in the future.
Humans ; Acupuncture Therapy/methods* ; Machine Learning ; Male ; Adult ; Female ; Subcutaneous Tissue/diagnostic imaging* ; Young Adult

OBJECTIVE: The relationship between fish consumption and stroke is inconsistent, and it is uncertain whether this association varies across predicted stroke risks. METHODS: A cohort study comprising 95,800 participants from the Prediction for Atherosclerotic Cardiovascular Disease Risk in China project was conducted. A standardized questionnaire was used to collect data on fish consumption. Participants were stratified into low- and moderate-to-high-risk categories based on their 10-year stroke risk prediction scores. Hazard ratios ( HRs) and 95% confidence intervals ( CIs) were estimated using Cox proportional hazard models and additive interaction by relative excess risk due to interaction (RERI), attributable proportion (AP), and synergy index (SI). RESULTS: During 703,869 person-years of follow-up, 2,773 incident stroke events were identified. Higher fish consumption was associated with a lower risk of stroke, particularly among moderate-to-high-risk individuals ( HR = 0.53, 95% CI: 0.47-0.60) than among low-risk individuals ( HR = 0.64, 95% CI: 0.49-0.85). A significant additive interaction between fish consumption and predicted stroke risk was observed (RERI = 4.08, 95% CI: 2.80-5.36; SI = 1.64, 95% CI: 1.42-1.89; AP = 0.36, 95% CI: 0.28-0.43). CONCLUSION Higher fish consumption was associated with a lower risk of stroke, and this beneficial association was more pronounced in individuals with moderate-to-high stroke risk.
Humans ; China/epidemiology* ; Male ; Female ; Stroke/etiology* ; Middle Aged ; Prospective Studies ; Incidence ; Aged ; Animals ; Fishes ; Risk Factors ; Diet ; Seafood ; Adult ; Cohort Studies